Siemens (NYSE:SI) Healthineers said today it won FDA clearance for its Biograph Vision positron emission tomography and computed tomography system. The newly cleared PET/CT scanner features the company’s Optiso ultra dynamic range detector technology, which is based on silicon photomultipliers instead of the industry standard photomultiplier tubes. Siemens said that the new system reduces the detector’s lutetium oxyorthosilicate […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
FDA warns of 5 new deaths from liquid-filled intragastric balloons
Updated to include response from Apollo Endosurgery The FDA today released a notice warning of five new patient deaths related to two liquid-filled intragastric balloon systems used to treat obesity, produced by Apollo Endosurgery (NSDQ:APEN) and ReShape Lifesciences (NSDQ:RSLS). The additional deaths bring the total number of deaths worldwide from the Orbera intragastric balloon and ReShape integrated […]
Camber Spine wins FDA nod for combining existing tech
Camber Spine Technologies has won 510(k) clearance from the FDA to market its ENZA-A Titanium Anterior Lumbar Interbody Fusion (ALIF) system, which leverages two of its existing technologies. The new device borrows from the Wayne, Penn.-based company’s first-generation ENZA, which has dual-grip anchor technology, and from its Spira line, which use spiral support arches to […]
FDA labels Medtronic Heartware recall as Class I
The FDA last Friday labeled a Medtronic (NYSE:MDT) voluntary select recall of its HeartWare HVAD systems over issues with unexpected power source switching as Class I. A Class I recall is the federal watchdog’s most serious class of recall, indicating the potential for serious injury or death. The devices are being recalled over possible interruptions in the […]
FDA clears Insulet’s Omnipod Dash insulin management system
Insulet (NSDQ:PODD) said today that the FDA granted 510(k) clearance to its Omnipod Dash insulin management system. The system wirelessly connects the company’s Personal Diabetes Manager with its tubeless, waterproof insulin pump. The PDM calculates how much insulin should be administered using blood glucose readings from the Contour Next One blood glucose meter. Altogether, the system […]
Power morcellation: Questions linger for controversial tech
Dr. Amy Reed’s tragic case brought to light the cancer risks posed by power morcellation. Her death hasn’t stopped lingering questions about the technology. Power morcellators were used for 20 years to laparoscopically remove fibroids, benign tumors of the uterus, raising not a single adverse event report with the FDA. That all changed in 2013, […]
Korea’s IntroMedic wins FDA nod for MiroCam capsule endoscope, inks U.S. distro deal
Korea-based medtech company IntroMedic inked a deal with Stratis Medical to distribute its MicroCam video capsule endoscopy system in the U.S. The device is designed to visualize and monitor the small bowel mucosa. The MicroCam is the first capsule endoscopy system with E-Field Propagation or Human Body Communication, according to Stratis Medical – the proprietary […]
FDA’s Gottlieb: Drug shortages are an ‘inevitable consequence of an imperfect system’
When doctors and nurses are faced with a shortage of medically necessary drugs, they are forced to make challenging decisions about how to ration whatever they have left. FDA commissioner Dr. Scott Gottlieb is looking to identify ways that the U.S. regulatory agency can help prevent and predict these shortages. In a statement this week, […]
EMA committee recommends approval for migraine prevention drug
Novartis (NYSE:NVS) said today that a committee for the European Medicines Agency has recommended that the regulatory agency approve Aimovig, a self-administered drug designed to prevent migraines in adults who have at least four migraine days each month. The drug is the first of a new class of medicines, called CGRP inhibitors. It’s a monoclonal antibody […]
Apotex recalls allergy nasal spray due to glass particles
Apotex yesterday issued a voluntary recall of one lot of fluticasone propionate allergy nasal spray devices, noting that they may contain small glass particles. The company first discovered the issue thanks to a customer complaint. The glass particles could block the device’s actuator, according to Apotex, and impact the pump’s functionality. Get the full story at […]
Intuitive Surgical wins expanded clearance for da Vinci SP
Intuitive Surgical (NSDQ:ISRG) said today that it won 510(k) clearance from the FDA for a new indication for its da Vinci SP robot-assisted surgery device and revealed plans to pursue other indications for the single-port device. Initially cleared in April 2014 for urological procedures, the da Vinci SP’s newest indication is for procedures requiring very narrow access from a […]